Program is subject to change.
PRE-RECORDED LECTURES
Novel Trial Designs
James Doroshow, NCI Division of Cancer Treatment and Diagnosis, Bethesda, Maryland*
*Pre-recorded lecture only, will not be attending onsite
Leveraging Large Datasets in Clinical Trial Design
Thomas Braun, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan
Workshop Pretest
Completed online between Saturday, July 22 and Sunday, July 23
SUNDAY, JULY 23
Registration
1:30 pm-5:30 pm
Faculty Meeting
4:30 pm-5:15 pm
Welcome/Overview
5:30 pm-5:45 pm
Manuel Hidalgo, Weill Cornell Medicine, New York Presbyterian Hospital, New York, New York
Jamie Von Roenn, American Society of Clinical Oncology, Alexandria, Virginia
Margaret Foti, American Association for Cancer Research, Philadelphia, Pennsylvania
Opening Keynote Lecture
Session Chair: Manuel Hidalgo, Weill Cornell Medicine, New York Presbyterian Hospital, New York, New York
5:45 pm-6:30 pm
- Career Development Opportunities: The Government Can Help
Oliver Bogler, National Cancer Institute, Rockville, Maryland
Dinner
6:30 pm-7:15 pm
Protocol Development Group Session
7:30 pm-9:00 pm
MONDAY, JULY 24
Breakfast
7:00 am-8:00 am
Lecture Session 1
Session Chair: Julie M. Vose, University of Nebraska Medical Center, Omaha, Nebraska
8:00 am-10:00 am
- Clinical Trial Design: Asking Important Questions that Impact Our Patients
Julie M. Vose, University of Nebraska Medical Center, Omaha, Nebraska - Answering Important Questions: From Hypothesis to Analysis
Thomas M. Braun, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan - Phase I Trial Questions
Manuel Hidalgo, Weill Cornell Medicine, New York Presbyterian Hospital, New York, New York - Phase I Trial Designs
Nolan A. Wages, Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia
Questions / Panel Discussion
Break
10:00 am-10:20 am
Lecture Session 2
Session Chair: Maha Hussain, Northwestern University Feinberg School of Medicine, Chicago, Illinois
10:20 am-12:00 pm
- Phase II Trial Questions/Objectives
Maha Hussain, Northwestern University Feinberg School of Medicine, Chicago, Illinois - Phase II Trial Designs
Sean Devlin, Memorial Sloan Kettering Cancer Center, New York, New York - Drug Combination Trials
Manish Shah, Weill Cornell Medical College, New York, New York - Multimodality Trials
Karyn Goodman, Icahn School of Medicine at Mount Sinai, New York, New York
Questions / Panel Discussion
Lunch
12:00 pm-1:30 pm
Protocol Development Group 2
1:30 pm-4:00 pm
Independent Study Time
4:00 pm-7:00 pm
Personalized Mentoring Session (Biostatisticians and Patient Advocates; prescheduled appointments)
4:30 pm-6:30 pm
ASSIGNMENT DUE: PROTOCOL TEMPLATE
7:00 pm
Dinner
7:00 pm-9:00 pm
TUESDAY, JULY 25
Breakfast
7:30 am-8:30 am
Lecture Session 3
Session Chair: Wendy B. London, Boston Children’s Hospital/Dana-Farber Cancer Institute Boston, Massachusetts
8:30 am-10:00 am
- Feasibility and Reproducibility in Biomarker Studies
Kurt A. Schalper, Yale University, New Haven, Connecticut - Incorporation of Biological Correlative Studies into Early Clinical Trials
Taofeek K. Owonikoko, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania - Statistical Aspects of Correlative Studies
Wendy B. London, Boston Children’s Hospital/Dana-Farber Cancer Institute, Boston, Massachusetts
Questions / Panel Discussion
Break
10:00 am-10:30 am
Lecture Session 4
Session Chair: Ezra Cohen, Tempus Labs, La Jolla, California
10:30 am-12:00 pm
- Imaging in the Era of Targeted Therapy and Immunotherapy
Thomas E. Yankeelov, The University of Texas, Austin, Texas - Special Considerations in the Design of Immunotherapy Studies
Ezra Cohen, Tempus Labs, La Jolla, California - Barriers to Accrual and How to Overcome Them
Ruth O’Regan, University of Rochester, Rochester, New York
Questions / Panel Discussion
Lunch
12:00 pm-12:45 pm
Protocol Development Group Session 3
12:45 pm-3:45 pm
Break
3:45 pm-4:00 pm
Personalized Mentoring Session: Protocol Related Questions
4:00 pm-6:00 pm
Room locations noted on signup sheets
(Signup sheets will be available during the morning break.)
Independent Study Time
3:45 pm-7:00 pm
Pizza and salads available from 5:00 pm-7:00 pm
ASSIGNMENT DUE: STATISTICAL DESIGN
7:00 pm
WEDNESDAY, JULY 26
Breakfast
7:00 am-8:00 am
Small Group Discussion Sessions 1-3
8:00 am-9:00 am
- Elements of Artificial Intelligence
Thomas E. Yankeelov, The University of Texas, Austin, Texas
Carole Baas, NCI Physical Sciences in Oncology Network, Southlake, Texas - Symptom Management, Patient Reported Outcomes, and Quality of Life
Tanya Wildes, Univeristy of Nebraska Medical Center, Omaha, Nebraska
Shing Lee, Columbia University, New York, New York
Jill Feldman, EGFResiters, Evanston, Illinois - Phase III Trials
Lindsay Renfro, University of Southern California, Los Angeles, California
Elizabeth Plimack, Fox Chase Cancer Center, Philadelphia, Pennsylvania
Josh Mailman, NorCal CarciNET Community, Oakland, California
Break
9:00 am-9:15 am
Small Group Discussion Sessions 4-6
9:15 am-10:15 am
- Navigating the National Clinical Trials Network
Colin Weekes, Massachusetts General Hospital, Boston, Massachusetts
Vijaya Bhatt, University of Nebraska Medical Center, Omaha, Nebraska - Incorporation of Digital Health and PROs
Adam Dicker, Thomas Jefferson University Kimmel Cancer Center, Philadelphia, Pennsylvania
Sujata Patil, The Cleveland Clinic, Cleveland, Ohio
Josh Mailman, NorCal CarciNET Community, Oakland, California - Laboratory Correlates
Ruth O’Regan, University of Rochester, Rochester, New York
Kurt A. Schalper, Yale University, New Haven, Connecticut
Break / Group Photo
10:15 am-10:45 am
Small Group Discussion Sessions 7-9
10:45 am-11:45 am
- Defining, Identifying, and Knowing Your Trial’s Clinical Endpoints
John Byrd, University of Cincinnati College of Medicine, Cincinnati, Ohio
Chen Hu, Johns Hopkins University, Baltimore, Maryland
Sanford Jeames, PCORI/Huston-Tillotson University, Austin, Texas - First in Human Trials: Understanding the Regulatory Process
Franklin Smith, Medpace, Cincinnatti, Ohio
Douglas Yee, Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota - Large-Scale Genomic Analysis: Bench to Bedside
Manish Shah, Weill Cornell Medical College, New York, New York
Manju George, Colontown, Crowdsville, Maryland
Lunch
11:45 am-12:30 pm
Protocol Development Group Session 4
12:30 pm-2:30 pm
Independent Study Time/Dinner on Own
2:30 pm-7:00 pm
ASSIGNMENT DUE: PROTOCOL DRAFTS
7:00 pm
THURSDAY, JULY 27
Breakfast
7:00 am-8:00 am
Lecture Session 5
Session Chair: Manish A. Shah, Weill Cornell Medical College, New York, New York
8:00 am-9:40 am
- You’re in Charge: Investigator Responsibilities
Manish A. Shah, Weill Cornell Medical College, New York, New York - How to Pay for Your Trial
Douglas Yee, Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota - Everything You Need to Know About Clinical Trial Ethics and Informed Consent
Laura C. Michaelis, Medical College of Wisconsin, Milwaukee, Wisconsin
Diana T. Chingos, DTC Consulting, Los Angeles, California - Community Engagement
Sanford Jeames, PCORI/Huston-Tillotson University, Austin, Texas
Questions / Panel Discussion
Break
9:40 am-9:55 am
Lecture Session 6
Session Chair: Mark Krailo, University of Southern California, Los Angeles, California
9:55 am-11:35 am
- Data Collection: It’s All In the Data
Mark Krailo, University of Southern California, Los Angeles, California - Inclusivity in Clinical Trials
Colin Weekes, Massachusetts General Hospital, Boston, Massachusetts
Everett E. Dodson, Georgetown Lombardi Comprehensive Cancer Center (Retired), Washington DC
Questions / Panel Discussion
Break
11:35 am-11:45 am
Keynote Lecture
Session Chair: Julie M. Vose, University of Nebraska Medical Center, Omaha, Nebraska
11:45 am-12:35 pm
- Patricia M. LoRusso, Yale Cancer Center, New Haven, Connecticut
Lunch
12:35 pm-1:30 pm
Protocol Development Group Session 5
1:30 pm-3:00 pm
Independent Study Time/Dinner on Own
3:00 pm-7:00 pm
Personalized Mentoring Session
3:30 pm-5:00 pm
Room locations noted on signup sheets
(Signup sheets will be available during the morning breaks.)
Optional Networking Session: Women in Hematology/Oncology
5:15 pm-6:15 pm
ASSIGNMENT DUE: INFORMED CONSENT DOCUMENTS
7:00 pm
FRIDAY, JULY 28
Breakfast
7:00 am-8:30 am
Faculty Meeting (Faculty Only)
7:30 am-8:30 am
Optional Career Sessions
(Exact topics to be determined based on accepted applicant interests, topics shown below are examples from past Workshops)
8:30 am-9:30 am
- Collaborating and Networking
Maura Dickler, Genentech, New York, New York
Andrew M. Lowy, University of California, San Diego, San Diego, California
Nathalie McKenzie, AdventHealth Cancer Institute, Orlando, Florida - Work-Life Balance
Jeff Bogart, State University of New York, Syracuse, New York
Tari King, Dana-Farber Cancer Institute/Brigham and Women’s Cancer, Boston, Massachusetts
Franklin O. Smith, Medpace, Cincinnati, Ohio - Career Transition and Advancement Tips
Ezra Cohen, Tempus Labs, La Jolla, California
Taofeek K. Owonikoko, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
Elizabeth Plimack, Fox Chase Cancer Center, Philadelphia, Pennsylvania
Break
9:30 am-9:45 am
Lecture Session 7
Session Chair: Alex A. Adjei, Cleveland Clinic, Cleveland, Ohio
9:45 am-11:10 am
- Successful Grantsmanship
Alex A. Adjei, Cleveland Clinic, Cleveland, Ohio - Reporting and Presenting Results
Shing Lee, Columbia University, New York, New York
Tari King, Dana-Farber Cancer Institute/Brigham and Women’s Cancer Center, Boston, Massachusetts
Questions / Panel Discussion
Break
11:10 am-11:20 pm
Protocol Development Group Session 6
11:20 am-1:00 pm
Lunch (Boxed)
1:00 pm-1:30 pm
Administration of Post-test
1:30 pm-2:30 pm
Independent Study Time
2:30 pm-7:00 pm
ASSIGNMENT DUE: FINAL PROTOCOLS, INFORMED CONSENT FORMS, and ALL WORKSHOP EVALUATIONS
7:00 pm
Closing Reception / Banquet / Dance
7:00 pm-11:00 pm
SATURDAY, JULY 29
Departure (on own)